Sympathetic Overactivity in Post-traumatic Stress Disorder (SO-PTSD)

This study is currently recruiting participants.
Verified October 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Jeanie Park, Emory University
ClinicalTrials.gov Identifier:
NCT01627301
First received: June 21, 2012
Last updated: October 15, 2013
Last verified: October 2013

June 21, 2012
October 15, 2013
July 2012
June 2016   (final data collection date for primary outcome measure)
Sympathetic activity [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01627301 on ClinicalTrials.gov Archive Site
  • Inflammatory markers [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Ambulatory Blood Pressure [ Time Frame: 0 weeks and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sympathetic Overactivity in Post-traumatic Stress Disorder
Mechanisms of Sympathetic Overactivity in Post-traumatic Stress Disorder

Patients with post-traumatic stress disorder (PTSD)and prehypertension (borderline high blood pressure) are at higher risk for developing high blood pressure and heart disease. The purpose of this study is to test whether PTSD patients have exaggerated increases in blood pressure, heart rate, and adrenaline levels during different forms of stress, that might predispose them to developing high blood pressure and heart disease. This study will also evaluate whether regular sessions of slow breathing that is guided by a device (RESPeRATE) improves blood pressure, heart rate, and adrenaline levels during stress in patients with PTSD and prehypertension.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post-traumatic Stress Disorder
  • Prehypertension
Device: Device-Guided Breathing using the RESPeRATE device
15 minutes of device-guided breathing daily for 8 weeks
  • Experimental: Device-Guided Breathing
    Intervention: Device: Device-Guided Breathing using the RESPeRATE device
  • Active Comparator: Calm Music
    Intervention: Device: Device-Guided Breathing using the RESPeRATE device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prehypertensive Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/ Operation New Dawn (OND) veterans with PTSD
  • Prehypertensive OEF/OIF/OND veterans without PTSD (controls)

Exclusion Criteria:

  • hypertension
  • diabetes
  • current smoker
  • heart or vascular disease
  • illicit drug use
  • excessive alcohol use (>2 drinks per day)
  • hyperlipidemia
  • autonomic dysfunction
  • treatment with medications known to affect the sympathetic nervous system (clonidine, beta blockers, ACE inhibitors)
  • treatment with MAO inhibitors within the last 14 days
  • any serious systemic disease.
Both
18 Years to 65 Years
Yes
Contact: Jeanie Park, MD 404-321-6111 ext 5178 jeanie.park@emory.edu
United States
 
NCT01627301
IRB00054697
No
Jeanie Park, Emory University
Emory University
Not Provided
Principal Investigator: Jeanie Park, MD Emory University and the Atlanta VA Medical Center
Emory University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP